Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies

Abstract Background The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA). Methods Patients with active PsA who were biologic-naive (SPIRIT-P1) or had p...

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Main Authors: Bernard Combe, Tsen-Fang Tsai, J. Eugene Huffstutter, Aubrey Trevelin Sprabery, Chen-Yen Lin, So Young Park, Andris Kronbergs, Matthew M. Hufford, Peter Nash
Format: Article
Language:English
Published: BMC 2021-01-01
Series:Arthritis Research & Therapy
Subjects:
Online Access:https://doi.org/10.1186/s13075-020-02388-5
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spelling doaj-b16932c648be4716aed14c4aba8b6e9a2021-01-31T16:39:12ZengBMCArthritis Research & Therapy1478-63622021-01-0123111010.1186/s13075-020-02388-5Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studiesBernard Combe0Tsen-Fang Tsai1J. Eugene Huffstutter2Aubrey Trevelin Sprabery3Chen-Yen Lin4So Young Park5Andris Kronbergs6Matthew M. Hufford7Peter Nash8Department of Rheumatology, CHU Montpellier, Montpellier UniversityNational Taiwan UniversityArthritis AssociatesEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanySchool of Medicine, Griffith UniversityAbstract Background The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA). Methods Patients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses. Results Out of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1 year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX. Conclusions In this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1 year of treatment, with or without concomitant MTX therapy. Trial registration ClinicalTrials.gov NCT01695239 and NCT02349295 .https://doi.org/10.1186/s13075-020-02388-5Psoriatic arthritisIxekizumabcDMARDsMethotrexate
collection DOAJ
language English
format Article
sources DOAJ
author Bernard Combe
Tsen-Fang Tsai
J. Eugene Huffstutter
Aubrey Trevelin Sprabery
Chen-Yen Lin
So Young Park
Andris Kronbergs
Matthew M. Hufford
Peter Nash
spellingShingle Bernard Combe
Tsen-Fang Tsai
J. Eugene Huffstutter
Aubrey Trevelin Sprabery
Chen-Yen Lin
So Young Park
Andris Kronbergs
Matthew M. Hufford
Peter Nash
Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
Arthritis Research & Therapy
Psoriatic arthritis
Ixekizumab
cDMARDs
Methotrexate
author_facet Bernard Combe
Tsen-Fang Tsai
J. Eugene Huffstutter
Aubrey Trevelin Sprabery
Chen-Yen Lin
So Young Park
Andris Kronbergs
Matthew M. Hufford
Peter Nash
author_sort Bernard Combe
title Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
title_short Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
title_full Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
title_fullStr Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
title_full_unstemmed Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies
title_sort ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of psa: week 52 results from spirit-p1 and spirit-p2 studies
publisher BMC
series Arthritis Research & Therapy
issn 1478-6362
publishDate 2021-01-01
description Abstract Background The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA). Methods Patients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses. Results Out of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1 year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX. Conclusions In this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1 year of treatment, with or without concomitant MTX therapy. Trial registration ClinicalTrials.gov NCT01695239 and NCT02349295 .
topic Psoriatic arthritis
Ixekizumab
cDMARDs
Methotrexate
url https://doi.org/10.1186/s13075-020-02388-5
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